Search Results
Found 4 results
510(k) Data Aggregation
(77 days)
Ask a specific question about this device
(66 days)
The Dasm MRI/Conventional Biopsy Set consists of two parts, the Daum BiopsyGun and the Daum CoaxNeedle. The BiopsyGun is used for automatic biopsy of soft tissues, and the CoaxNeedle is intended for use in open and percutaneous surgical procedures of the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle,
The Dasm MRI/Conventional Biopsy Set consists of two parts, the Daum BiopsyGun and the Daum CoaxNeedle. The BiopsyGun is used for automatic biopsy of soft tissues, and the CoaxNeedle is intended for use in open and percutaneous surgical procedures of the brain. The patented surface treatment of the needle optimizes its use in the MRI setting, producing a low-artifact visualization of the needle,
The provided text is a 510(k) clearance letter from the FDA for the "Daum MRI/Conventional Biopsy Set." This document confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The 510(k) clearance process focuses on substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the clearance letter itself. Such studies, if conducted, would typically be part of the submission package to the FDA, but they are not summarized or detailed in this particular letter.
Ask a specific question about this device
(50 days)
The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.
The Daum NeuroGate Trocar is a reusable surgical instrument made of titanium, which is to be inserted into the skull. The insertion is done with the aid of an insertion tool. This trocar function is for inserting and fixing of needles and instruments. NeuroGate trocar is available with several channel diameters (I IG, 14G, 16G) allowing a combination with all Daum neuro needles.
The provided document is a 510(k) clearance letter from the FDA for a device called "Daum NeuroGate Trocar". This document only states that the device is substantially equivalent to a predicate device and can be marketed. It does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide the requested information based on the given context. The document is a regulatory approval, not a scientific study report.
Ask a specific question about this device
(65 days)
Ask a specific question about this device
Page 1 of 1